Modular valve prosthesis, delivery system, and method of delivering and deploying a modular valve prosthesis

ABSTRACT

A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.15/186,593, filed Jun. 20, 2016, now allowed, the contents of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to heart valve prostheses and methods fordelivering and deploying heart valve prostheses. More particularly, thepresent invention relates to a modular valve prosthesis. The presentinvention also relates to a delivery device including a capsule with aplurality of sections and flexible bands between such sections.

BACKGROUND

Heart valves are sometimes damaged by disease or by aging, resulting inproblems with the proper functioning of the valve. Heart valvereplacement has become a routine surgical procedure for patientssuffering from valve dysfunctions. Traditional open surgery inflictssignificant patient trauma and discomfort, requires extensiverecuperation times, and may result in life-threatening complications.

To address these concerns, efforts have been made to perform cardiacvalve replacements using minimally-invasive techniques. In thesemethods, laparoscopic instruments are employed to make small openingsthrough the patient's ribs to provide access to the heart. Whileconsiderable effort has been devoted to such techniques, widespreadacceptance has been limited by the clinician's ability to access onlycertain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheter(or transluminal) delivery and implantation of replacement cardiacvalves to solve the problems presented by traditional open surgery andminimally-invasive surgical methods. In such methods, a stentedprosthetic heart valve, of valve prosthesis, is compacted for deliveryin a catheter and then advanced, for example through an opening in thefemoral artery, and through the descending aorta to the heart, where thevalve prosthesis is then deployed in the valve annulus (e.g., the aorticvalve annulus).

Various types and configurations of valve prostheses are available forpercutaneous valve replacement procedures. In general, valve prosthesisdesigns attempt to replicate the function of the valve being replacedand thus will include valve leaflet-like structures. Valve prosthesesare generally formed by attaching a bioprosthetic valve to a frame madeof a wire or a network of wires. Such a stented prosthetic heart valvecan be compressed radially to introduce the stented prosthetic heartvalve into the body of the patient percutaneously through a catheter.The stented prosthetic heart valve may be deployed by radially expandingit once positioned at the desired treatment site.

Often, the ability to traverse the tortuous vasculature prior toreaching the treatment site is limited by the state of the diseaseand/or varying anatomical size of the vasculature.

Accordingly, there is a need for valve prostheses and delivery systemsfor valve prostheses that are sufficiently flexible to navigate tortuousvessel. In particular, there is a need for modular valve prostheses,delivery systems, and methods of guiding and aligning modules of suchmodular valve prostheses during deployment.

SUMMARY OF THE INVENTION

Embodiments hereof relate to a modular valve prosthesis including aninflow stent, a valve component, and an outflow stent. The modular valveprosthesis includes a radially collapsed delivery configuration and aradially expanded deployed configuration. The inflows stent includes aninflow end and an outflow end. The valve component includes a valvestent and a prosthetic valve coupled to the valve stent such that theprosthetic valve is disposed in an interior lumen of the valve stent.The valve stent includes an inflow end and an outflow end. The inflowend of the valve stent faces the outflow end of the inflow stent. Theoutflow stent includes an inflow end and an outflow end. The inflow endof the outflow stent faces the outflow end of the valve stent. When themodular valve prosthesis is in the radially collapsed deliveryconfiguration, the inflow end of the valve stent is not in contact withthe outflow end of the inflow stent and the outflow end of the valvestent is not in contact with the inflow end of the outflow stent. Whenthe modular valve prosthesis is in the radially expanded deployedconfiguration, the inflow end of the valve stent is in contact with theoutflow end of the inflow stent and the outflow end of the valve stentis in contact with the inflow end of the outflow stent.

Embodiments hereof also relate to a delivery system for delivering amodular valve prosthesis including an outer sheath surrounding an innershaft. The outer sheath includes a capsule at a distal portion thereof.The capsule is configured to maintain the modular valve prosthesis in aradially compressed delivery configuration for delivery to a treatmentsite. The capsule is configured to be retracted to release the modularvalve prosthesis at the treatment site. The capsule includes a firstsection and a second section. The first section and the second sectionare aligned with corresponding first and second modules of the modularvalve prosthesis when the modular valve prosthesis is in the radiallycompressed delivery configuration. The capsule includes a first bandbetween the first section and the second section, and the first band isconfigured to be aligned with a first gap between the first module andthe second module of the modular valve prosthesis when the modular valveprosthesis is in the radially compressed delivery configuration. Thefirst band is more flexible than each of the first section and thesecond section.

Embodiments hereof also relate to a method for delivering and deployinga modular valve prosthesis. The method includes manipulating a deliverysystem loaded with the modular valve prosthesis in a radially compresseddelivery configuration through a patient's vasculature to a treatmentsite. The modular valve prosthesis includes an inflow stent, a valvecomponent, and an outflow stent. The delivery system includes an outersheath including a capsule. The capsule includes a first section, asecond section, a third section, a first band disposed between the firstsection and the second section, and a second band disposed between thesecond section and the third section. The modular valve prosthesis isloaded within the capsule with the inflow stent aligned with the firstsection, a first gap between the inflow stent and the valve componentaligned with the first band, the valve component aligned with the secondsection, a second gap between the valve component and the outflow stentaligned with the second band, and the outflow stent aligned with thirdsection. The delivery system further includes a plurality of suturescoupled to a hub and extending through each of the inflow stent, thevalve component, and the outflow stent. The method includes retractingthe capsule such that the inflow stent is released from the capsule andtransitions from the radially compressed delivery configuration to aradially expanded deployed configuration. The method further includesretracting the hub such that the sutures are taut. The method furtherincludes further retracting the capsule such that the valve component isreleased from the capsule. The valve component transitions from theradially compressed delivery configuration to the radially expandeddeployed configuration and couples with the inflow stent. The methodfurther includes retracting the hub such that the sutures are taut. Themethod further includes further retracting the hub to release theoutflow stent from the capsule. The outflow stent transitions from theradially compressed delivery configuration to the radially expandeddeployed configuration and couples with the valve component.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective illustration of an embodiment of a modular valveprosthesis according to an embodiment hereof, wherein the modular valveprosthesis is in a radially expanded deployed configuration.

FIG. 2 is a perspective illustration of the modular valve prosthesis ofFIG. 1 in a radially expanded deployed configuration, with the modulesseparated for viewing clarity.

FIG. 3A is an end illustration of the inflow end of the inflow stent ofFIG. 1.

FIG. 3B is an end illustration of the outflow end of the inflow stent ofFIG. 1.

FIG. 4A is an end illustration of the inflow end of the valve componentof FIG. 1.

FIG. 4B is an end illustration of the outflow end of the valve componentof FIG. 1.

FIG. 5A is an end illustration of the inflow end of the outflow stent ofFIG. 1.

FIG. 5B is an end illustration of the outflow end of the outflow stentof FIG. 1.

FIG. 6A is a close-up perspective illustration of an embodiment of alocking mechanism of the modular valve prosthesis of FIG. 1 in anunlocked configuration.

FIG. 6B is a close-up perspective illustration of the locking mechanismof FIG. 6A in a compressed configuration.

FIG. 6C is a close-up perspective illustration of the locking mechanismof FIG. 6A in a locked configuration.

FIG. 7 is a perspective illustration of a modular valve prosthesisaccording to another embodiment hereof.

FIG. 8 is a perspective illustration of the modular valve prosthesis ofFIG. 7 in a radially expanded deployed configuration, with the modulesseparated for viewing clarity.

FIG. 9A is an end illustration of the inflow end of the inflow stent ofFIG. 7.

FIG. 9B is an end illustration of the outflow end of the inflow stent ofFIG. 7.

FIG. 10A is an end illustration of the inflow end of the valve componentof FIG. 7.

FIG. 10B is an end illustration of the outflow end of the valvecomponent of FIG. 7.

FIG. 11A is an end illustration of the inflow end of the outflow stentof FIG. 7.

FIG. 11B is an end illustration of the outflow end of the outflow stentof FIG. 7.

FIG. 12A is a close-up perspective illustration of an embodiment of alocking mechanism of the modular valve prosthesis of FIG. 7 in anunlocked configuration.

FIG. 12B is a close-up perspective illustration of the locking mechanismof FIG. 12A in a compressed configuration.

FIG. 12C is a close-up perspective illustration of the locking mechanismof FIG. 12A in a locked configuration.

FIG. 13 is exploded perspective illustration of a delivery systemaccording to an embodiment hereof.

FIG. 14 is a side illustration of a distal portion of the deliverysystem of FIG. 13.

FIG. 15 is side illustration of the distal portion of the deliverysystem of FIG. 13 with a modular valve prosthesis in a radiallycollapsed delivery configuration contained within a capsule of thedelivery system.

FIGS. 16A and 16B are close-up illustrations of a suture detachingmechanism of the delivery system of FIG. 13.

FIGS. 17-21 are simplified illustrations of a method of delivering anddeploying a modular valve prosthesis according to an embodiment hereof.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to acatheter or delivery system are with respect to a position or directionrelative to the treating clinician. Thus, “distal” and “distally” referto positions distant from, or in a direction away from the clinician and“proximal” and “proximally” refer to positions near, or in a directiontoward the clinician. When the terms “distal” and “proximal” are used inthe following description to refer to a device to be implanted into anative artery, such as a modular valve prosthesis, they are used withreference to the direction of blood flow from the heart. Thus “distal”and “distally” refer to positions in a downstream direction with respectto the direction of blood flow and “proximal” and “proximally” refer topositions in an upstream direction with respect to the direction ofblood flow.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Furthermore, there is no intention to be bound by anyexpressed or implied theory presented in the preceding technical field,background, brief summary, or the following detailed description.

In general terms, the modular valve prosthesis of the present disclosureincludes an inflow stent, a valve component, and an outflow stent. Themodular valve prosthesis includes a radially compressed deliveryconfiguration for delivery to a treatment site and a radially expandeddeployed configuration when deployed at the treatment site. The modularvalve prosthesis is configured to be delivered to the treatment site asseparate modules (unassembled), and assembled at the treatment site.

With the above understanding in mind, a modular valve prosthesis 100according to an embodiment of the present invention is shown in FIGS.1-7C. Modular valve prosthesis 100 includes a first or inflow stent 110,a valve component 120, and a third or outflow stent 140, as shown inFIG. 1. In an embodiment, modular valve prosthesis 100 further includesa plurality of first locking mechanisms 160 for coupling inflow stent110 and valve component 120 together, and a plurality of second lockingmechanism 162 for coupling valve component 120 and outflow stent 140together, as described in more detail below. Modular valve prosthesis100 includes a radially compressed delivery configuration (not shown)for delivery to the treatment site of a native valve and a radiallyexpanded deployed configuration, as shown in FIG. 1. Modular valveprosthesis 100 may be self-expanding or balloon expandable based uponthe application. Components in accordance with the embodiment of modularvalve prosthesis 100 of FIG. 1 are presented in greater detail in FIGS.2-6C. Various features of the components of modular valve prosthesis 100reflected in FIGS. 1-6C and described below can be modified or replacedwith differing structures and/or mechanisms. Modular valve prosthesis100, described in greater detail below, is merely an exemplaryembodiment of a percutaneous modular valve prosthesis according to anembodiment hereof and modifications can be made to the embodimentsdescribed herein, without departing from the spirit and scope of thepresent invention. The present disclosure is in no way limited to inflowstent 110, valve component 120, and outflow stent 140 shown anddescribed below. Components of modular valve prosthesis 100 may assumedifferent forms and construction based upon application needs asdescribed in greater detail in for example, U.S. Pat. No. 8,226,710 toNguyen incorporated in its entirety by reference herein. Therefore, thefollowing detailed description is not meant to be limiting. Further, thesystems and functions described below can be implemented in manydifferent embodiments of hardware. Any actual hardware described is notmeant to be limiting. The operation and behavior of the systems andmethods presented are described with the understanding thatmodifications and variations of the embodiments are possible given thelevel of detail presented.

Inflow stent 110, as shown in FIGS. 1-3B, is of a generally tubularconfiguration, and includes a radially compressed delivery configurationand a radially expanded deployed configuration. Inflow stent 110includes an inflow end 112 and an outflow end 114, and defines an inflowlumen 118 therein. Inflow stent 110 further includes a plurality ofsuture guides 119, and a plurality of lock loops 174 corresponding tofirst locking mechanisms 160. Inflow stent 110 further includes anoutflow flange 116.

In an embodiment, suture guides 119 are disposed about an interiorcircumference of inflow stent 110, extending into inflow lumen 118, asshown in FIGS. 3A-3B. In an embodiment, a set of suture guides 119 isdisposed at inflow end 112 of inflow stent 110, as shown in FIG. 3A, anda set of suture guides 119 is disposed at outflow end 114 of inflowstent 110, as shown in FIG. 3B. Suture guides 119 are configured toretain sutures 150, described below, therethrough. More particularly,suture guides 119 provide routing of sutures 150 through inflow stent110. Suture guides 119 may be configured, for example, and not by way oflimitation, as rings, hooks, loops, or any other configuration suitablefor purposes of the present disclosure. In an embodiment, there arethree (3) suture guides 119 at the inflow end 112 and the outflow end114. However, more or fewer suture guides 119 may be used. They alsoneed not be located at the ends of inflow stent 110, as shown.

In an embodiment, lock loops 174 of first locking mechanisms 160 aredisposed about an exterior circumference of inflow stent 110 at outflowend 114 of inflow stent 110, as shown in FIG. 3B. More particularly,lock loops 174 of first locking mechanisms 160 are configured to coupleto a plurality of corresponding lock portions 164 of first lockingmechanisms 160 to couple inflow stent 110 to valve stent 122, asdescribed in greater detail below. In an embodiment, there are three (3)lock loops 174 spaced equally circumferentially about inflow stent 110.However, more or fewer lock loops 174 may be used and they need not beequally spaced.

Outflow flange 116 is disposed at outflow end 114 of inflow stent 110.More particularly, outflow flange 116 of inflow stent 110 is configuredto abut a corresponding inflow flange 128 of valve component 120 when inthe radially expanded deployed configuration, as shown in FIG. 1. Whenabutting against corresponding inflow flange 128 of valve stent 122,outflow flange 128 aids in sealing inflow stent 110 to valve stent 122.Outflow flange 114 of inflow stent 110 may be formed, for example, andnot by way of limitation, of silicone, fabric, polyester, rubber basedmaterials, tissue/pericardium, and/or a foam/open cell structure.

Inflow stent 110 may be formed, for example, and not by way oflimitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or composite having elastic propertiesto permit extension and recoil suitable for purposes of the presentdisclosure.

Valve component 120 is of a generally tubular configuration, is disposeddistally or downstream of inflow stent 110, and includes a radiallycompressed delivery configuration and a radially expanded deployedconfiguration. Valve component 120 includes a second or valve stent 122and a prosthetic valve 134. Valve stent 122 includes an inflow end 126and an outflow end 130, and defines a valve lumen 124 therein. Valvestent 122 further includes a plurality of suture guides 125, a pluralityof lock portions 164 corresponding to first locking mechanisms 160, aplurality of lock loops 194 corresponding to second locking mechanisms162, an inflow flange 128, and an outflow flange 132, as shown in FIGS.1-2 and FIGS. 4A-4B.

In an embodiment, suture guides 125 are disposed about an interiorcircumference of valve stent 122, extending into valve lumen 124. In anembodiment, a set of suture guides 125 is disposed at inflow end 126 ofvalve stent 122, as shown in FIG. 4A, and a set of suture guides 125 isdisposed at outflow end 130 of valve stent 122, as shown in FIG. 4B.Suture guides 125 are configured to retain sutures 150, described below,therethrough. More particularly, suture guides 125 provide routing ofsutures 150 through valve stent 122 and alignment of valve component 120relative to inflow stent 110, as described in greater detail below.Suture guides 125 may be configured, for example, and not by way oflimitation, as rings, hooks, loops, or any other configuration suitablefor purposes of the present disclosure. In an embodiment, there arethree (3) suture guides 125 at each of the inflow end 126 and theoutflow end 130. However, more or fewer suture guides 125 may be used.Further, they may be disposed other than at the inflow and outflow endsof valve stent 122

In an embodiment, lock portions 164 of first locking mechanisms 160 aredisposed about an exterior circumference of valve stent 122 at inflowend 126, as shown in FIGS. 2 and 4A. More particularly, lock portions164 of first locking mechanisms 160 are configured to couple tocorresponding lock loops 174 of first locking mechanisms 160 in order tocouple valve stent 122 to inflow stent 110, as described in greaterdetail below. In an embodiment, there are three (3) lock portions 164spaced equally circumferentially about valve stent 122. However, more orfewer lock portions 164 may be used and they need not be equally spaced.

In an embodiment, lock loops 194 of second locking mechanisms 162 aredisposed about the exterior circumference of valve stent 122 at outflowend 130, as shown in FIGS. 2 and 4B and described in greater detailbelow. More particularly, lock loops 194 of second locking mechanisms162 are configured to couple to corresponding lock portions 184 ofsecond locking mechanisms 162 in order to couple valve stent 122 tooutflow stent 140, as described in greater detail below. In anembodiment, there are three (3) lock loops 194 spaced equallycircumferentially about valve stent 122. However, more or fewer lockloops 194 may be used and they need not be equally spaced.

Inflow flange 128 is disposed at inflow end 126 of valve stent 122 andoutflow flange 132 is disposed at outflow end 130 of valve stent 122.More particularly, inflow flange 128 of valve stent 122 is configured toabut with corresponding outflow flange 116 of inflow stent 110 andoutflow flange 132 of valve stent 122 is configured to abut with acorresponding inflow flange 144 of outflow stent 140 when in theradially expanded deployed configuration, as shown in FIG. 1. Whenabutting against corresponding flanges 116/144, flanges 128/132 aid insealing valve stent 122 to inflow stent 110 and outflow stent 140,respectively. Flanges 128/132 of valve stent 122 may be formed, forexample, and not by way of limitation, of silicone, fabric, polyester,rubber based materials, tissue/pericardium, and/or a foam/open cellstructure.

Prosthetic valve 134 is disposed within interior lumen 124 of valvestent 122, as shown in FIGS. 1-2 and can assume a variety ofconfigurations described in greater detail in for example, U.S. Pat. No.8,226,710 to Nguyen, previously incorporated herein. In an embodiment,as shown in FIGS. 4A-4B, prosthetic valve 134 comprises three (3)leaflets 134 a, 134 b, 134 c. However, more or fewer leaflets, such as abi-leaflet design, may be utilized.

Valve stent 122 may be formed, for example, and not by way oflimitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or composite having elastic propertiesto permit extension and recoil suitable for purposes of the presentdisclosure. Prosthetic valve 134 may be formed of materials as are knownin the art.

Outflow stent 140 is of a generally tubular configuration, and includesa radially compressed delivery configuration and a radially expandeddeployed configuration. Outflow stent 140 includes an inflow end 142 andan outflow end 146, and defines an outflow lumen 148 therein. Outflowstent 140 further includes a plurality of suture guides 149, a pluralityof lock portions 184 of second locking mechanisms 162, and an inflowflange 144, as shown in FIGS. 1-2 and FIGS. 5A-5B.

In an embodiment, suture guides 149 are disposed about an interiorcircumference of outflow stent 140, as shown in FIGS. 5A-5B. In anembodiment, a set of suture guides 149 is disposed at inflow end 142 ofoutflow stent 140, as shown in FIG. 5A, and a set of suture guides 149is disposed at outflow end 146 of outflow stent 140, as shown in FIG.5B. Suture guides 149 are configured to retain sutures 150, describedbelow, therethrough. More particularly, suture guides 149 providerouting of sutures 150 through outflow stent 140 and alignment ofoutflow stent 140 relative to valve component 120 and inflow stent 110.Suture guides 149 may be configured, for example, and not by way oflimitation, as rings, hooks, loops, or any other configuration suitablefor purposes of the present disclosure. In an embodiment, there arethree (3) suture guides 149 at each of the inflow end 142 and theoutflow end 146. However, more or fewer suture guides 149 may be used.Further, they need not be disposed at the inflow and outflow ends ofoutflow stent 140.

In an embodiment, lock portions 184 of second locking mechanisms 162 aredisposed about the exterior circumference of outflow stent 140 at inflowend 142, as shown in FIG. 5A. More particularly, lock portions 184 ofsecond locking mechanisms 162 are configured to couple to correspondinglock loops 194 of second locking mechanisms 162 to couple outflow stent140 to valve stent 122, as described in greater detail below.

Inflow flange 144 is disposed at inflow end 142 of outflow stent 140.More particularly, inflow flange 144 of outflow stent 140 is configuredto abut with corresponding outflow flange 132 of valve stent 122 ofvalve component 120 when in the radially expanded deployedconfiguration, as shown in FIG. 1. When abutting against correspondingoutflow flange 132 of valve stent 122, inflow flange 144 and outflowflange 132 aid in sealing outflow stent 140 to valve stent 122. Inflowflange 144 of outflow stent 140 may be formed, for example, and not byway of limitation, of silicone, fabric, polyester, rubber basedmaterials, tissue/pericardium, and/or a foam/open cell structure.

Outflow stent 140 may be formed, for example, and not by way oflimitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or composite having elastic propertiesto permit extension and recoil suitable for purposes of the presentdisclosure.

As explained above, a set of first locking mechanisms 160 couple inflowstent 110 to valve stent 122, and a set of second locking mechanisms 162couple valve stent 122 to outflow stent 140. In an embodiment, firstlocking mechanisms 160 and second locking mechanisms are disposed aboutthe exterior circumference of respective inflow stent 110, valvecomponent 120, and outflow stent 140 of modular valve prosthesis 100, aspreviously described. First locking mechanisms 160 and second lockingmechanisms 162 include an unlocked configuration, a compressedconfiguration, and a locked configuration. As explained above, and shownin more detail in FIGS. 6A-6C, first locking mechanisms 160 and secondlocking mechanisms 162 include lock portions 164/184 and lock loops174/194, respectively. In an embodiment, lock portions 164/184 include apair of legs 170A/170B disposed between a proximal end 166 and a distalend 168. Legs 170A/170B are joined adjacent proximal end 166. A gap 186separates first leg 170A and second leg 170B distal of where they arejoined. First leg 170A and second leg 170B each include a shoulder172A/172B extending from an outer surface thereof outwardly relative toa longitudinal axis LA of lock portion 164/184. Distal of shoulders172A/172B, each leg includes a ramp 175A/175B such that the outersurface tapers back toward the longitudinal axis LA towards distal end168. Lock loops 174/194 include a frame loop 176 defining a loop lumen178 therein.

Lock portions 164/184 and lock loops 174/194 are configured such that astatic width WS₁ at shoulders 172A/172B is greater than a static widthW52 of lock lumen 178 of lock loops 174/194, as shown in FIG. 6A. Lockportions 164/184 and lock loops 174/194 are further configured such thatdistal end 168 of lock portion 164/184 fits within loop lumen 178. Aslock portion 164/184 is advanced through lock loop 174/194, or lock loop174/194 is advanced over lock portion 164/184, ramps 175A/175B of legs170A/170B contact an inner surface 188 of lock loop 174/194 definingloop lumen 178. As lock portion 164/184 continues to advance throughloop lumen 178, pressure of inner surface 188 against ramps 175A/175Bcompress legs 170A/170B towards each other, reducing gap 186, as shownin FIG. 6B, such that shoulders 172A/172B may traverse loop lumen 178 oflock loop 174/194. Lock portions 164/184 and lock loops 174/194 arefurther configured such that once shoulders 172A/17B traverse loop lumen178, legs 170A/170B move away from each other, as shown in FIG. 6C.Shoulders 172A/172B prevent lock loop 174/194 from moving distallyrelative to lock portion 164/184. Lock portions 164/184 and lock loops174/174 may be formed, for example, and not by way of limitation, ofstainless steel, Nitinol, nylon, polybutester, polypropylene, polyesteror other materials suitable for the purposes described herein. FIGS.6A-6C show one example of first and second locking mechanisms 160/162.Those skilled in the art would recognize that other locking mechanismssuitable for purposes of the present disclosure may be utilized. Forexample, and not by way of limitation, the locking mechanism describedwith respect to FIGS. 12A-12C below may be utilized.

According to embodiments hereof, valve component 120 is configured to bedisposed at outflow end 114 of inflow stent 110 and outflow stent 140 isconfigured to be disposed at outflow end 130 of valve stent 122 of valvecomponent 120, as shown in FIG. 1. More particularly, inflow flange 128of valve stent 122 of valve component 120 is configured to contactoutflow flange 116 of inflow stent 110, and inflow flange 144 of outflowstent 140 is configured to contact outflow flange 132 of valve stent 122of valve component 120 when in the radially expanded deployedconfiguration. Stated another way, when modular valve prosthesis 100 isin the radially expanded deployed configuration, outflow flange 116 isin contact with inflow flange 128, and outflow flange 132 is in contactwith inflow flange 144. Outward radial forces of inflow stent 110, valvecomponent 120, and outflow stent 140 imparted against walls at thenative valve when the modular valve prosthesis 100 is in the radiallyexpanded deployed configuration maintains positioning of modular valveprosthesis 100 within the affected valve and maintains contact of inflowflange 128 of valve stent 122 of valve component 120 with outflow flange116 of inflow stent 110, and outflow flange 132 of valve stent 122 ofvalve component 120 with inflow flange 144 of outflow stent 140.

FIGS. 1 and 2 also show sutures 150 disposed through the interior ofinflow stent 110, valve component 120, and outflow stent 140 of modularvalve prosthesis 100. Sutures 150 are shown in FIG. 2 with modular valveprosthesis 100 in the radially expanded deployed configuration with themodules thereof separated for clarity and explanation purposes only.Sutures 150 are coupled to a delivery system, as described below, anddisposed within/through suture guides 119 of inflow stent 110, sutureguides 125 of valve component 120, and suture guides 149 of outflowstent 140 when in the radially compressed delivery configuration suchthat inflow stent 110, valve component 120, and outflow stent 140 may beproperly aligned at a treatment site upon deployment thereof, as shownin FIGS. 1-2 and described in greater detail below. Sutures 150 areconfigured such that sutures 150 radially and longitudinally align valvecomponent 120 with inflow stent 110 and radially and longitudinallyalign outflow stent 140 with valve component 120. Sutures 150 may beformed, for example, and not by way of limitation, of stainless steel,Nitinol, nylon, polybutester, polypropylene, silk, polyester or othermaterials suitable for the purposes described herein.

A modular valve prosthesis 200 according to another embodiment of thepresent invention is shown in FIGS. 7-12C. Modular valve prosthesis 200includes a first or inflow stent 210, a valve component 220, and a thirdor outflow stent 240, as shown in FIG. 7. In an embodiment, modularvalve prosthesis 200 further includes a plurality of first lockingmechanisms 260 for coupling inflow stent 210 and valve component 220together, and a plurality of second locking mechanisms 262 for couplingvalve component 220 and outflow stent 240 together, as described in moredetail below. Modular valve prosthesis 200 includes a radiallycompressed delivery configuration (not shown) for delivery to thetreatment site of a native valve and a radially expanded deployedconfiguration, as shown in FIG. 7. Modular valve prosthesis 200 may beself-expanding or balloon expandable based upon the application.Components in accordance with the embodiment of modular valve prosthesis200 of FIG. 7 are presented in greater detail in FIGS. 8-12C. Variousfeatures of the components of modular valve prosthesis 200 reflected inFIGS. 7-12C and described below can be modified or replaced withdiffering structures and/or mechanisms. Modular valve prosthesis 200,described in greater detail below, is merely an exemplary embodiment ofa percutaneous modular valve prosthesis according to an embodimenthereof and modifications can be made to the embodiments describedherein, without departing from the spirit and scope of the presentinvention. The present disclosure is in no way limited to inflow stent210, valve component 220, and outflow stent 240 shown and describedbelow. Components of modular valve prosthesis 200 may assume differentforms and construction based upon application needs as described ingreater detail in for example, U.S. Pat. No. 8,226,710 to Nguyenincorporated in its entirety by reference herein. Therefore, thefollowing detailed description is not meant to be limiting. Further, thesystems and functions described below can be implemented in manydifferent embodiments of hardware. Any actual hardware described is notmeant to be limiting. The operation and behavior of the systems andmethods presented are described with the understanding thatmodifications and variations of the embodiments are possible given thelevel of detail presented.

In an embodiment, inflow stent 210, as shown in FIGS. 7-9C, is of agenerally tubular configuration, and includes a radially compresseddelivery configuration and a radially expanded deployed configuration.Inflow stent 210 includes an inflow end 212 and an outflow end 214, anddefines an inflow lumen 218 therein. Inflow stent 210 further includes aplurality of suture guides 219, and a plurality of lock loops 274corresponding to first locking mechanisms 260.

In an embodiment, suture guides 219 are disposed about an interiorcircumference of inflow stent 210, as shown in FIGS. 9A-9B. In anembodiment, a set of suture guides 219 is disposed at inflow end 212 ofinflow stent 210, as shown in FIG. 9A, and a set of suture guides 219 isdisposed at outflow end 214 of inflow stent 210, as shown in FIG. 9B.Suture guides 219 are configured to retain sutures 250, described below,therethrough. More particularly, suture guides 219 provide routing ofsutures 250 through inflow stent 210. Suture guides 219 may beconfigured, for example, and not by way of limitation, as rings, hooks,loops, or any other configuration suitable for purposes of the presentdisclosure. In an embodiment, there are three (3) suture guides 219 atthe inflow end 212 and the outflow end 214. However, more or fewersuture guides 219 may be used. Further, they need not be located at theinflow and outflow ends of inflow stent 210.

In an embodiment, lock loops 274 of first locking mechanisms 260 aredisposed about the interior circumference of inflow stent 210, extendinginto inflow lumen 218, at outflow end 214 of inflow stent 210, as shownin FIG. 9B. More particularly, lock loops 274 of first lockingmechanisms 260 are configured to couple to a plurality of correspondinglock portions 264 of first locking mechanisms 260 to couple inflow stent210 to valve stent 212, as described in greater detail below. In anembodiment, there are three (3) lock loops 174 spaced equallycircumferentially about inflow stent 110. However, more or fewer lockloops 174 may be used and they need not be equally spaced.

Outflow end 214 of inflow stent 210 is configured to be connected to acorresponding inflow end 226 of valve stent 222 of valve component 220when in the radially expanded deployed configuration, as shown in FIG.7. Inflow stent 210 may be formed, for example, and not by way oflimitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or composite having elastic propertiesto permit extension and recoil suitable for purposes of the presentdisclosure.

Valve component 220 is of a generally tubular configuration, is disposeddistally of inflow stent 210, and includes a radially compresseddelivery configuration and a radially expanded deployed configuration.Valve component 220 includes a valve stent 222 and a prosthetic valve234. Valve stent 222 includes an inflow end 226 and an outflow end 230,and defines a valve lumen 124 therein. Valve stent 222 further includesa plurality of suture guides 225, a plurality of lock portions 264corresponding to first locking mechanisms 260, and a plurality of lockportions 284 corresponding to second locking mechanisms 262, as shown inFIGS. 7-8 and FIGS. 10A-10B.

In an embodiment, suture guides 225 are disposed about an interiorcircumference of valve stent 222, extending into valve lumen 224. In anembodiment, a set of suture guides 225 is disposed at inflow end 226 ofvalve stent 122, as shown in FIG. 10A, and a set of suture guides 225 isdisposed at outflow end 230 of valve stent 222, as shown in FIG. 10B.Suture guides 225 are configured to retain sutures 250, described below,therethrough. More particularly, suture guides 225 provide routing ofsutures 250 through valve stent 222 and alignment of valve component 220relative to inflow stent 210 and outflow stent 240, as described ingreater detail below. Suture guides 225 may be configured, for example,and not by way of limitation, as rings, hooks, loops, or any otherconfiguration suitable for purposes of the present disclosure. In anembodiment, there are three (3) suture guides 225 at each of the inflowend 226 and the outflow end 230 spaced equally around an innercircumference of valve stent 222. However, more or fewer suture guides225 may be used and they need not be equally spaced.

In an embodiment, lock portions 264 of first locking mechanisms 260 aredisposed about the interior circumference of valve stent 222 at inflowend 226, as shown in FIG. 10A. More particularly, lock portions 264 offirst locking mechanisms 260 are configured to couple to correspondinglock loops 274 of first locking mechanisms 260 in order to couple valvestent 122 to inflow stent 210, as described in greater detail below. Inan embodiment, there are three (3) lock portions 264 spaced equallycircumferentially about valve stent 122. However, more or fewer lockportions 264 may be used and they need not be equally spaced.

In an embodiment, lock loops 294 of second locking mechanisms 262 aredisposed about the interior circumference of valve stent 222 at outflowend 230, as shown in FIG. 10B and described in greater detail below.More particularly, lock loops 294 of second locking mechanisms 262 areconfigured to couple to corresponding lock portions 284 of secondlocking mechanisms 262 in order to couple valve stent 222 to outflowstent 240, as described in greater detail below. In an embodiment, thereare three (3) lock loops 294 spaced equally circumferentially about theinterior of valve stent 222. However, more or fewer lock loops 294 maybe used and they need not be equally spaced.

Inflow end 226 of valve stent 222 of valve component 220 is configuredto connect to corresponding outflow end 214 of inflow stent 210, andoutflow end 230 of valve stent 222 of valve component 220 is configuredto connect to a corresponding inflow end 242 of outflow stent 240 whenin the radially expanded deployed configuration, as shown in FIG. 7.

Prosthetic valve 234 is disposed within valve lumen 224 of valve stent222, as shown in FIGS. 7-8 and 10A-10B, and can assume a variety ofconfigurations described in greater detail in, for example, U.S. Pat.No. 8,226,710 to Nguyen, previously incorporated by reference herein. Inan embodiment, as shown in FIGS. 10A-10B, prosthetic valve 234 comprisesthree (3) leaflets 234 a, 234 b, 234 c. However, more or fewer leaflets,such as a bi-leaflet design, may be utilized.

Valve stent 222 may be formed, for example, and not by way oflimitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or composite having elastic propertiesto permit extension and recoil suitable for purposes of the presentdisclosure. Prosthetic valve 234 may be formed of materials as are knownin the art and suitable for the purposes of the present disclosure.

Outflow stent 240 is of a generally tubular configuration, and includesa radially compressed delivery configuration and a radially expandeddeployed configuration. Outflow stent 240 includes an inflow end 242 andan outflow end 246, and defines an outflow lumen 248 therein. Outflowstent further includes a plurality of suture guides 249, and a pluralityof lock portions 284 of second locking mechanisms 262, as shown in FIGS.7-8 and FIGS. 11A-11B.

In an embodiment, suture guides 249 are disposed about an interiorcircumference of outflow stent 240, as shown in FIGS. 11A-11B. In anembodiment, a set of suture guides 249 is disposed at inflow end 242 ofoutflow stent 240, as shown in FIG. 11A, and a set of suture guides 249is disposed at outflow end 246 of outflow stent 240, as shown in FIG.11B. Suture guides 249 are configured to retain sutures 250, describedbelow, therethrough. More particularly, suture guides 249 providerouting of sutures 250 through outflow stent 240 and alignment ofoutflow stent 240 relative to valve component 220 and inflow stent 210.Suture guides 249 may be configured, for example, and not by way oflimitation, as rings, hooks, loops, or any other configuration suitablefor purposes of the present disclosure. In an embodiment, there arethree (3) suture guides 249 equally spaced about the interiorcircumference of outflow stent 240 at each of the inflow end 242 and theoutflow end 246. However, more or fewer suture guides 249 may be usedand they need not be equally spaced. Further, they may be disposed otherthan at the inflow and outflow ends of outflow stent 240.

In an embodiment, lock portions 284 of second locking mechanisms 262 aredisposed about the interior circumference of outflow stent 240 at inflowend 242, as shown in FIG. 11A. More particularly, lock portions 284 ofsecond locking mechanisms 262 are configured to couple to correspondinglock loops 294 of second locking mechanisms 262 to couple outflow stent240 to valve stent 222, as described in greater detail below.

Inflow end 242 of outflow stent 240 is configured to connect tocorresponding outflow end 230 of valve stent 222 of valve component 220when in the radially expanded deployed configuration, as shown in FIG.7. Outflow stent 240 may be formed, for example, and not by way oflimitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or composite having elastic propertiesto permit extension and recoil suitable for purposes of the presentdisclosure.

As explained above, a set of first locking mechanisms 260 couple inflowstent 210 to valve stent 222, and a set of second locking mechanisms 262couple valve stent 222 to outflow stent 240. In an embodiment firstlocking mechanisms 260 and second locking mechanisms 262 are disposedabout an interior circumference of respective inflow stent 210, valvestent 222, and outflow stent 240 of modular valve prosthesis 200. Firstlocking mechanisms 260 and second locking mechanisms 262 include anunlocked configuration, a compressed configuration, and a lockedconfiguration. As explained above, and shown in more detail in FIGS.12A-12C, first and second locking mechanisms 260/262 include lockportions 264/284 and lock loops 274/294, respectively. Lock portions264/284 include a bulge portion 270 disposed between a proximal end 266and a distal end 268. Bulge portion 270 may be configured as a ring orloop, as shown in FIGS. 12A-12C. Bulge portion 270 includes an opening288 extending therethrough such that bulge portion 270 is shaped like aring or doughnut or torus. Lock portion 264/284 further includes asloped outer surface 275 between distal end 268 and a widest portion ofbulge portion 270 such that distal end 268 has a smaller width thanbulge portion 270. Lock loops 274/294 include a frame loop 276 defininga loop lumen 278 therethrough.

Lock portions 264/284 and lock loops 274/294 are configured such that astatic width WS₄ of bulge portion 270 is greater than a static width WS₅of lumen 278 of lock portions 264/284, as shown in FIG. 12A. Lockportions 264/284 and lock loops 274/294 are further configured such thatdistal end 268 of lock portions 264/284 fit within loop lumen 278. Aslock portion 264/284 is advanced through loop lumen 278, or lock loop274/294 is advanced over lock portion 264/284, sloped outer surface 275contacts inner surface 288 of lock loop 274/294 defining loop lumen 278.As lock portion 264/284 continues to advance through loop lumen 278,pressure of inner surface 288 against sloped surface 275 compressesbulge portion 270, reducing the width of opening 288, as shown in FIG.12B. Lock portions 264/284 and lock loops 274/294 are further configuredsuch that once bulge portion 270 traverses lock loop 274/294, bulgeportion 270 expands to its original width WS₃ such that lock portion264/284 and lock loop 274/294 are coupled to one another. Stated anotherway, lock portion 264/284 may be pressed through lock loop 274/294, andwhen so pressed therethrough, will couple lock portion 264/284 to lockloop 274/294. Lock portions 264/284 and lock loops 274/294 may beformed, for example, and not by way of limitation, of stainless steel,Nitinol, nylon, polybutester, polypropylene, silk, polyester or othermaterials suitable for the purposes described herein.

FIGS. 12A-12C show one example of first and second locking mechanisms260/262. Those skilled in the art would recognize that other lockingmechanisms suitable for purposes of the present disclosure may beutilized. For example, and not by way of limitation, the lockingmechanisms described with respect to FIGS. 6A-6C above may be utilized.

According to embodiments hereof, valve component 220 is configured to bedisposed at outflow end 214 of inflow stent 210 and outflow stent 240 isconfigured to be disposed at outflow end 230 of valve stent 222 of valvecomponent 220, as shown in FIG. 8. More particularly, inflow end 226 ofvalve stent 222 of valve component 220 is configured to contact outflowend 214 of inflow stent 210, and inflow end 242 of outflow stent 240 isconfigured to contact outflow end 230 of valve stent 222 of valvecomponent 220 when in the radially expanded deployed configuration.Stated another way, when modular valve prosthesis 200 is in the radiallyexpanded deployed configuration, outflow end 114 is in contact withinflow end 226, and outflow end 230 is in contact with inflow end 242.Outward radial forces of inflow stent 210, valve component 220, andoutflow stent 240 imparted against native artery walls when in themodular valve prosthesis 200 is in the radially expanded deployedconfiguration maintains positioning of modular valve prosthesis 200within the affected artery and maintains contact of inflow end 226 ofvalve stent 222 of valve component 220 with outflow end 214 of inflowstent 210, and outflow end 230 of valve stent 222 of valve component 220with inflow end 242 of outflow stent 240.

FIGS. 7 and 8 also show sutures 250 disposed through the interior ofinflow stent 210, valve component 220, and outflow stent 240 of modularvalve prosthesis 200. Sutures 250 are shown in FIG. 8 with modular valveprosthesis 200 in the radially expanded deployed configuration with themodules separated for clarity and explanation purposes only. Sutures 250are coupled to a delivery system, as described below, and are disposedthrough suture guides 249 of outflow stent 240, suture guides 225 ofvalve stent 222, and suture guides 219 of inflow stent 210 when modularvalve prosthesis 200 is in the radially compressed deliveryconfiguration, such that inflow stent 210, valve component 220, andoutflow stent 240 may be properly aligned at a treatment site upondeployment thereof, as shown in FIGS. 7-8 and described in greaterdetail below. Sutures 250 may be formed, for example, and not by way oflimitation, of stainless steel, Nitinol, nylon, polybutester,polypropylene, silk, polyester or other materials suitable for thepurposes described herein.

Although two embodiments of a modular valve prosthesis (modular valveprosthesis 100 and modular valve prosthesis 200) have been describedabove, they are not meant to be limiting. Further, each of the featuresof modular valve prosthesis 100 can be interchanged with each of thefeatures of modular valve prosthesis 200. For example, and not by way oflimitation, the first and second locking mechanisms of each embodimentmay be disposed on the exterior of the respective stent or the interiorof each respective stent. Further, the first and second lockingmechanisms may be aligned with the respective stents (not shown).Further, the locking mechanisms shown in FIGS. 6A-6C may be used witheither embodiment or variations thereof, or the locking mechanisms ofFIGS. 12A-12C may be used with either embodiment or variations thereof.Further, either embodiment or variations thereof may or may not includeflanges.

A delivery system 300 according to an embodiment hereof is shown inFIGS. 13-16B. Delivery system 300 includes a handle 310, an outer sheath320, an inner shaft 340, a plurality of sutures 350, and a hub assembly330. Components in accordance with the embodiment of delivery system 300of FIGS. 13-16B, are described in greater detail below. Various featuresof the components of delivery system 300 reflected FIGS. 13-16B anddescribed below can be modified or replaced with different structuresand or mechanisms. Delivery system 300, described in greater detailbelow, is merely an exemplary embodiment of a transcatheter deliverysystem according to embodiment hereof and modifications can be made tothe embodiments described herein without departing from the spirit andscope of the present invention. The present disclosure is in no waylimited to the handle 310, outer sheath 320, inner shaft 340, sutures350, and hub assembly 330 shown and described below. Components ofdelivery system 300 may assume different forms and construction basedupon application needs. Further, the systems and functions describedbelow can be implemented in many different embodiments of hardware. Anyactual hardware described is not meant to be limiting.

Handle 310 includes a housing 312 and a plurality of actuator mechanisms314/316 retained therein. More particularly, handle 310 is configured tomaintain portions of actuator mechanisms 314/316 within a cavity (notshown), defined by housing 312, as shown in FIG. 13. In the embodimentshown in FIG. 13, housing 310 further forms a plurality of longitudinalslots 315/317 (slot 317 is obscured in FIG. 13 by handle housing 312)through which actuator mechanisms 314/316 extend, respectively, forinterfacing by a user. Handle 310 provides a surface for convenienthandling and grasping by a user, and can have a generally cylindricalshape as shown. While handle 310 of FIG. 13 is shown with a cylindricalshape, it is not meant to limit the design, and other shapes and sizesare contemplated based on the application requirements. Handle 310 canassume a variety of configurations described in greater detail in U.S.Pat. No. 8,579,963 to Tabor, which is incorporated in its entirety byreference herein. Actuator mechanism 314 is generally constructed toprovide selective retraction/advancement of outer sheath 320, includinga proximal shaft 324 and a capsule 321, and can have a variety ofconstructions and/or devices capable of providing the desired userinterface. Actuator mechanism 316 is generally constructed to provideselective retraction/advancement of hub assembly 330, including a hubshaft 334 and a hub 331, and can have a variety of constructions and/ordevices capable of providing the desired user interface.

Outer sheath 320 is coaxially and slidably disposed about the outercircumference of hub assembly 330 and inner shaft 340 as shown in FIGS.14-15. Stated another way, outer sheath 320 may be longitudinally movedrelative to hub assembly 330 and inner shaft 340, as described in moredetail herein. With reference to FIGS. 13-16B, outer sheath 320 includescapsule 321, a proximal shaft 324, and defines a lumen 328 extendingfrom a proximal end 325 of proximal shaft 324 to a distal end 323 ofcapsule 321. Outer sheath 320 further includes a suture detachingmechanism 370 described in greater detail below. Although outer sheath320 is described herein as including capsule 321 and proximal shaft 324,capsule 321 may simply be an extension of proximal shaft 324. The lengthand thickness of capsule 321 are determined by the requirements of thespecific application.

Capsule 321 includes a first section 360, a second section 362, and athird section 364, as shown in FIGS. 14-15. Capsule 321 is configuredsuch that when a modular valve prosthesis, such as modular valveprosthesis 200, is radially compressed within capsule 321 for delivery,inflow stent 210, valve component 220, and outflow stent 240 are alignedwith first section 360, second section 362, and third section 364,respectively. Alternatively, inflow stent 210, valve component 220, andoutflow stent 240 are aligned with third section 364, second section362, and first section 360, respectively. Capsule 321 further includes afirst band 366 disposed between first section 360 and second section362, and a second band 368 disposed between second section 362 and thirdsection 364. With modular valve prosthesis 200 radially compressedwithin capsule 321 for delivery, a first gap 440 disposed between inflowstent 210 and valve component 220 is aligned with first band 366 and asecond gap 450 disposed between valve component 220 and outflow stent240 is aligned with second band 368. Alternatively, depending on theorientation of modular valve prosthesis disposed in capsule 321, firstgap 440 disposed between inflow stent 210 and valve component 220 may bealigned with second band 368 and second gap 450 disposed between valvecomponent 220 and outflow stent 240 may be aligned with first band 366.First band 366 is configured to be more flexible that first section 360and second section 362, and second band 368 is configured to be moreflexible that second section 362 and third section 364. For example, andnot by way of limitation, first and second bands 366, 368 may be made ofa different material than first, second, and third sections 360, 362,364. For example, and not by way of limitation, first and second bands366, 368 may be formed from a polymer construction while first, second,and third sections 360, 362, 364 may be metallic. In anothernon-limiting example, first and second bands 366, 368 may be made from apolymer construction, while first, second, and third sections 360, 362,364 may be formed from a reinforced polymer construction, such as byadding a metallic braid or weave to the polymer. In another non-limitingexample, first and second bands 366, 368 or first, second, and thirdsections 360, 362, 364 may be treated such that first and second bands366, 368 are more flexible than first, second, and third sections 360,362, 364. Although modular valve prosthesis 200 and components thereofare used to describe a modular valve prosthesis disposed within capsule321, this is not limiting. Other modular valve prostheses, such asmodular valve prosthesis 100 or other embodiments not specificallydescribed herein, may also be used. Further, the orientation of themodular valve prosthesis with respect to capsule 321 is not limiting.For example, and not by way of limitation, modular valve prosthesis maybe flipped such that inflow stent 210 may be aligned with third section364 instead of first section 362.

Proximal shaft 324 includes a detaching mechanism 370 coupled therein,as shown in FIGS. 13-16B and described in greater detail below. Proximalshaft 324 is configured for fixed connection to capsule 321 at aconnection point 327 at a proximal end 322 of capsule 321 for example,and not by way of limitation, by fusing, welding, adhesive, sutures, orother means suitable for the purposes described herein. Proximal shaft324 extends proximally from capsule 321 into housing 312 of handle 310,and a proximal portion 329 of proximal shaft 324 is rigidly connected toactuator mechanism 314 of handle 310. Proximal portion 329 is coupled toactuator mechanism 314 such that movement of actuator mechanism 314causes outer sheath 320 to move relative to inner shaft 340 and hub 331.Proximal shaft 324 may be coupled to actuator mechanism 314, forexample, and not by way of limitation by adhesives, welding, clamping,and other coupling devices as appropriate. Outer sheath 320 is thusmovable relative to handle 310, inner shaft 340, and hub 331 by actuatormechanism 314. However, if actuator mechanism 314 is not moved andhandle 310 is moved, outer sheath 320 moves with handle 310, notrelative to handle 310.

Hub assembly 330 is coaxially and slidably disposed between outer sheath320 and inner shaft 340 as shown in FIGS. 13-16B. Stated another way,hub assembly 330 may be longitudinally moved relative to outer sheath320 and inner shaft 340 as described in more detail herein. Withreference to FIGS. 13-16B, hub assembly 330 includes hub 331 and hubshaft 334, and defines a lumen 338 extending from a proximal end 335 ofhub shaft 334 to a distal end 333 of hub 331. Although hub assembly 330is described herein as including hub 331 and hub shaft 334, hub 331 maysimply be an extension of hub shaft 334.

Hub 331 is disposed within lumen 312 of outer sheath 320, between outersheath 320 and inner shaft 340 as shown in FIGS. 13-15 and shown ingreater detail in FIG. 16A-16B. Hub 331 provides a surface forconnection of sutures 350 as described in greater detail below. Hub 331is rigidly connected to hub shaft 334 at a connection point 337 forexample, and not by way of limitation, by adhesives, welding, clamping,and other coupling devices as appropriate. Hub 331 can assume a varietyof configurations.

Hub shaft 334 is configured for fixed connection to hub 331 at aconnection point 337 at a proximal end 332 of hub 331 for example, andnot by way of limitation, by fusing, welding, adhesive, sutures, orother means suitable for the purposes described herein. Hub shaft 334extends proximally from hub 331, with a proximal portion 339 of hubshaft 334 coupled to handle 310, as shown in FIGS. 13-15. Moreparticularly, hub shaft 334 of hub assembly 330 extends proximally intohousing 312 of handle 310 and proximal portion 339 of hub shaft 334 isrigidly connected to actuator mechanism 316 of handle 310. Proximalportion 339 is coupled to actuator mechanism 316 such that movement ofactuator mechanism 316 causes hub assembly 330 to move relative to innershaft 340 and outer sheath 320. Hub shaft 334 may be coupled to actuatormechanism 316, for example, and not by way of limitation, by adhesives,welding, clamping, and other coupling devices as appropriate. Hubassembly 330 is thus movable relative to handle 310, inner shaft 340,and outer sheath 320 by actuator mechanism 316. However, if actuatormechanism 316 is not moved and handle 310 is moved, hub assembly 330moves with handle 310, not relative to handle 310.

Inner shaft 340 extends within lumen 338 of hub assembly 330 and lumen328 of outer sheath 320, as shown in FIGS. 13-16B. Inner shaft 340includes a shaft 341, a retention member 344, and a tip 348 as shown inFIG. 15. Shaft 341 extends from a proximal end 342 of shaft 341 to adistal end 343 of shaft 341. Distal end 343 of shaft 341 connects or isattached to retention member 344, and retention member 344 connects oris attached to tip 348. The components of inner shaft 340 combine todefine a continuous lumen 349, which is sized to receive an auxiliarycomponent such as a guidewire (not shown). Although inner shaft 340 isdescribed herein as including shaft 341, retention member 344, and tip348, retention member 344 and tip 348 may simply be extensions of shaft341. Shaft 341 of inner shaft 340 extends proximally through housing 312of handle 310, and is rigidly connected to handle 310 such that lumen349 provides access for auxiliary components (e.g., a guidewire)therein. Shaft 341 may be coupled to handle 310, for example, and not byway of limitation, by adhesives, welding, clamping, and other couplingdevices as appropriate. During sliding or longitudinal movement of outersheath 320 relative thereto, inner shaft 340 is fixed relative to handle310. Inner shaft 340 can assume a variety of configurations described ingreater detail in U.S. Pat. No. 8,579,963 to Tabor, previouslyincorporated by reference herein.

Sutures 350 are elongated members as previously described and shown inFIGS. 13-15 and in greater detail in FIGS. 16A-16B. Each suture 350includes a first end 352 and a second end 354. Sutures 350 are disposedwithin lumen 328 of outer sheath 320. Each suture 350 extends from firstend 352 attached to hub 331, distally through outflow stent 240, valvecomponent 220, and inflow stent 210, and loops back proximally throughmodular valve prosthesis 200 to second end 354, which is also attachedto hub 331. Sutures 350 may be formed, for example, and not by way oflimitation, of stainless steel, Nitinol, nylon, polybutester,polypropylene, silk, polyester or other materials suitable for thepurposes described herein. First and second ends 352/354 of sutures 350are attached to hub 331 for example, and not by way of limitation, byfusing, welding, adhesives, tying or other methods suitable for thepurposes described herein.

A detaching mechanism 370 is disposed about an interior circumference ofproximal shaft 324 of outer sheath 320, between capsule 321 and hub 331.Detaching mechanism 370 is configured such that upon retraction ofproximal shaft 324, detaching mechanism 370 cuts or detaches a portion356 of sutures 350 as shown in FIG. 16B. Detaching mechanism 370 may beconfigured as a circumferential bump extending from an inner surface ofproximal shaft 324 towards a central longitudinal axis CLa, andextending around the entire inner circumference of proximal shaft 324,as shown in FIGS. 16A-16B. In other embodiments, detaching mechanism 370need not be continuous around the entire inner circumference of proximalshaft 324. Instead, detaching mechanism 370 may be a plurality of bumpsor protrusions extending from the inner surface of proximal shaft 324towards the central longitudinal axis CLa. In an embodiment shown inFIGS. 16A-16B, detaching mechanism 370 is configured such that uponretraction of proximal shaft 324, detaching mechanism 370 is retractedproximally towards and contacts hub 331, and thereby severing ordetaching a portion 356 of sutures 350, as shown in FIG. 16B. In anembodiment, at least one of first and second ends 352, 354 of eachsuture 350 remains attached to hub 331 such that sutures 350 areretracted with delivery system 300. Detaching mechanism 370 may beformed as part of proximal shaft 324, or may be attached to proximalshaft 324 for example, and not by way of limitation, by fusing, welding,adhesives, or other methods suitable for the purposes described herein.Further, detaching mechanism 370 is not limited to bumps or protrusions.Instead, other ways to sever or disconnect sutures 350 may be utilized.

While the delivery system of FIGS. 13-16B shows capsule 321 with threesections 360/362/364 and two bands 366, 368, this is not meant to limitthe design and more or fewer sections and bands are envisioned based onthe application.

While the delivery system of FIGS. 13-16B shows two sutures 350, it isunderstood that these are cross-sectional or side views such that thisembodiment may include more sutures 350, such as three sutures 350 tomatch the suture guides described above with respect to modular valveprostheses 100, 200. However, it is further understood that more orfewer sutures 350 may be used.

A method of delivering and deploying a modular valve prosthesisutilizing a delivery system, in accordance with an embodiment hereof, isschematically represented in FIGS. 17-21. FIGS. 17-21 show, and thedescription herein describes, modular valve prosthesis 100 beingdelivered and deployed using delivery system 300. However, this is notmeant to be limiting. In particular, a similar method may be used todeliver and deploy modular valve prosthesis 200 using delivery system300 or other delivery systems. Further, other delivery systems may beused to delivery and deploy modular valve prosthesis 100 or 200, orother modular valve prostheses.

With reference to FIG. 17, using established percutaneous transcatheterdelivery procedures, delivery system 300 is introduced into a patient'svasculature and advanced to a treatment site of a damaged or diseasednative valve, which in this embodiment is a native aortic valve 714.Delivery system 300 includes a handle (not shown), outer sheath 320,inner shaft 340, hub assembly 330, and sutures 350 as previouslydescribed. Capsule 321 of delivery system 300 retains modular valveprosthesis 100 in the radially collapsed delivery configuration,therein. Delivery system 300 is advanced through the aorta 700(including the aortic arch 704 (passing the innominate orbrachiocephalic artery 716, the left common carotid artery 718, and theleft subclavian artery 720), ascending aorta 702, sinotubular junction710, aortic sinuses 712) and to a valve annulus 708 and the site of thedamaged or disease native aortic valve 714, as shown in FIG. 17.

In another step of the method, actuator mechanism 314 of handle 310 (notshown on FIGS. 17-21) is operated proximally to retract outer sheath320, as shown in FIG. 18. In particular, proximal shaft 324 and capsule321 are moved proximally to withdraw capsule 321 from its positionsurrounding inflow stent 110 of modular valve prosthesis 100. As capsule321 is retracted proximally, inflow stent 110 transitions from theradially compressed delivery configuration to the radially expandeddeployed configuration. Capsule 321 is withdrawn sufficiently proximallysuch that distal edge 323 of capsule 321 is aligned with inflow end 124of valve component 120.

In another step of the method, actuator mechanism 316 of handle 310 (notshown on FIGS. 17-21) is operated proximally to retract hub assembly330. In particular, hub shaft 334 and hub 331 are moved proximally todraw sutures 350 taut.

In another step of the method, delivery system 300 is advanced distallyto ensure that distal edge 323 of capsule 321 is adjacent outflow end114 of inflow stent 110. As delivery system 300 is advanced, sutures 350are maintained taut. In another step of the method, actuator mechanism314 of handle 310 (not shown on FIGS. 17-21) is operated proximally tofurther retract outer sheath 320, as shown in FIG. 19. In particular,proximal shaft 324 and capsule 321 are moved proximally to withdrawcapsule 321 from its position surrounding valve component 120 of modularvalve prosthesis 100. As capsule 321 is retracted proximally, valvecomponent 120 transitions from the radially compressed deliveryconfiguration to the radially expanded deployed configuration, tautsutures 350 align valve component 120 with inflow stent 110, inflowflange 128 of valve component 120 contacts outflow flange 116 of inflowstent 110, and lock portions 164 of first locking mechanisms 160 ofvalve component 120 couple to lock loops 174 of first locking mechanisms160 of inflow stent 110. Stated another way, as valve component 120radially expands, it is aligned with, contacts, and is coupled to inflowstent 110.

In another step of the method, actuator mechanism 346 of handle 310 (notshown on FIGS. 17-21) is operated proximally to retract hub assembly330. In particular, hub shaft 334 and hub 331 are moved proximally todraw sutures 350 taut.

In another step of the method, delivery system 300 is advanced distallyto ensure that distal edge 323 of capsule 321 is adjacent outflow end130 of valve stent 122. As delivery system 300 is advanced, sutures 350are maintained taut. In another step of the method, actuator mechanism314 of handle 310 (not shown on FIGS. 17-21) is operated proximally tofurther retract outer sheath 320, as shown in FIG. 20. In particular,proximal shaft 324 and capsule 321 are moved proximally to withdrawcapsule 321 from its position surrounding outflow stent 140 of modularvalve prosthesis 100. As capsule 321 is retracted proximally, outflowstent 140 transitions from the radially compressed deliveryconfiguration to the radially expanded deployed configuration, tautsutures 350 align outflow stent 140 with valve component 120, inflowflange 144 of outflow stent 140 contacts outflow flange 132 of valvecomponent 120, and lock portions 184 of second lock mechanisms 162 ofoutflow stent 140 couple to lock loops 194 of second lock mechanisms 162of valve component 120. Stated another way, as outflow stent 140radially expands, it is aligned with, contacts, and is coupled to valvecomponent 120.

In another step of the method, actuator mechanism 314 of handle 310 (notshown on FIGS. 17-21) is operated proximally to further retract outersheath 320. In particular, proximal shaft 334 and detaching mechanism370 are moved proximally until detaching mechanisms 370 detach/severportion 356 of sutures 350.

In another step of the method, delivery system 300, with sutures 350attached thereto, is removed from the patient's vasculature usingestablished percutaneous transcatheter procedures. Modular valveprosthesis 100, including inflow stent 110, valve component 120, andoutflow stent 14, remains positioned at the treatment site, as shown inFIG. 21.

While the method of FIGS. 17-21 describe a method for deploying amodular valve prosthesis 100 with three modules, this is not meant tolimit the design and a similar method may be employed for modular valveprostheses with more or fewer modules by adding or deleting the steps ofactuating actuator mechanism 316 of handle 310 proximally to retract hubassembly 330 and actuating actuator mechanism 314 of handle 310proximally to further retract outer sheath 320 and release the nextmodule.

While the method of FIGS. 17-21 describes a method for deploying modularvalve prosthesis 100 including first locking mechanisms 160 and secondlocking mechanisms 162, this is not meant to limit the design and otherconfigurations are anticipated including modular valve prostheses withno first or second locking mechanisms. Further, modular valve prostheseswithout flanges 116, 118, 128, and 132 may be used, such as, but notlimited to, modular valve prosthesis 200.

Further, while the method of FIGS. 17-21 describes a method fordeploying a modular valve prosthesis by accessing a native aortic valvesite via the aorta, the method may be used to treat other valves, suchas but not limited to, the mitral valve. Further, other access routesmay be used, such as but not limited to, trans-apical, trans-atrial,trans-septal, and other access routes known to those skilled in the art.

While only some embodiments have been described herein, it should beunderstood that it has been presented by way of illustration and exampleonly, and not limitation. Various changes in form and detail can be madetherein without departing from the spirit and scope of the invention,and each feature of the embodiments discussed herein, and of eachreference cited herein, can be used in combination with the features ofany other embodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

1. A modular valve prosthesis comprising: an inflow stent having aninflow end and a outflow end; a valve component including a valve stentand a prosthetic valve coupled to the valve stent such that theprosthetic valve is disposed in an interior lumen of the valve stent,the valve stent having an inflow end and an outflow end, wherein theinflow end of the valve stent faces the outflow end of the inflow stent;and an outflow stent having an inflow end and an outflow end, whereinthe inflow end of the outflow stent faces the outflow end of the valvestent, wherein in a radially compressed delivery configuration, theinflow end of the valve stent is not in contact with the outflow end ofthe inflow stent and the outflow end of the valve stent is not incontact with the inflow end of the outflow stent, and wherein in aradially expanded deployed configuration, the inflow end of the valvestent is in contact with the outflow end of the inflow stent and theoutflow end of the valve stent is in contact with the inflow end of theoutflow stent.
 2. The modular valve prosthesis of claim 1, wherein theinflow end of the valve stent includes a flange that contacts acorresponding flange of the inflow stent in the radially expandeddeployed configuration.
 3. The modular valve prosthesis of claim 2,wherein the outflow end of the valve stent includes a flange thatcontacts a corresponding flange of the outflow stent in the radiallyexpanded deployed configuration.
 4. The modular valve prosthesis ofclaim 3, wherein the flanges comprise a material selected from the groupconsisting of silicone, fabric, polyester, rubber based materials,tissue/pericardium, and a foam/open cell structure.
 5. The modular valveprosthesis of claim 1, further comprising a plurality of suturesextending longitudinally through the inflow stent, the valve stent, andthe outflow stent in the delivery configuration, wherein the sutures areconfigured to be tightened during deployment of the modular valveprosthesis such that the inflow stent contacts the valve stent and theoutflow stent contacts the valve stent.
 6. The modular valve prosthesisof claim 5, further comprising a locking mechanism disposed between theinflow stent and the valve stent such that when the outflow end of theinflow stent is in contact with the inflow end of the valve stent in theradially expanded deployed configuration, the locking mechanism locksthe inflow stent and the valve stent together.
 7. The modular valveprosthesis of claim 6, further comprising a second locking mechanismdisposed between the valve stent and the outflow stent such that whenthe outflow end of the valve stent is in contact with the inflow end ofthe outflow stent in the radially expanded deployed configuration, thesecond locking mechanism locks the valve stent and the outflow stenttogether. 8-16. (canceled)
 17. A method of delivering and deploying amodular valve prosthesis comprising the steps of: manipulating adelivery system loaded with modular valve prosthesis in a radiallycompressed delivery configuration to guide the modular valve prosthesisthrough a patient's vasculature to a treatment site, wherein the modularvalve prosthesis comprises an inflow stent, a valve component, and anoutflow stent, wherein the delivery system comprises an outer sheathincluding a capsule, wherein the capsule includes a first section, asecond section, a third section, a first band disposed between the firstsection and the second section, and a second band disposed between thesecond section and the third section, wherein the modular valveprosthesis is loaded within the capsule with the inflow stent alignedwith the first section, a first gap between the inflow stent and thevalve component align with the first band, the valve component alignedwith the second section, a second gap between the valve component andthe outflow stent aligned with the second band, and the outflow stentaligned with third section, wherein the delivery system further includesa plurality of sutures coupled to a hub and extending through each ofthe inflow stent, the valve component, and the outflow stent; retractingthe capsule proximally to release the inflow stent from the capsule suchthat the inflow stent transitions from the radially compressed deliveryconfiguration to a radially expanded deployed configuration; retractingthe hub such that the sutures are taut; retracting the capsuleproximally to release the valve component from the capsule such that thevalve component transitions from the radially compressed deliveryconfiguration to the radially expanded deployed configuration and thevalve component couples with the inflow stent; retracting the hub suchthat the sutures are taut; and retracting the outer sheath proximally torelease the outflow stent from the capsule such that the outflow stenttransitions from the radially compressed delivery configuration to theradially expanded deployed configuration and the outflow stent coupleswith the valve component.
 18. The method of claim 17, wherein thedelivery system further comprises a detaching mechanism, furthercomprising the step of manipulating the delivery system after themodular valve prosthesis is in the radially expanded deployedconfiguration to sever or detach a portion of the sutures from the hub.19. The method of claim 17, wherein the modular valve prosthesis furthercomprises a locking mechanism and the step of coupling the valvecomponent with the inflow stent includes engaging the locking mechanismsuch that the locking mechanism locks the inflow stent and the valvecomponent together.
 20. The method of claim 19, wherein the modularvalve prosthesis further comprises a second locking mechanism and thestep of coupling the outflow stent with the valve component includesengaging the second locking mechanism such that the second lockingmechanism locks the valve component and the outflow stent together.